BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEDLINE MODULE PATIENT CABLE

    MDR report key: 4170474 · Received September 24, 2014

    Report

    Report Number
    2031172-2014-00207
    Event Type
    Death
    Date Received
    September 24, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    GWQ
    PMA / PMN Number
    K140188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN MADE. IT HAS BEEN INDICATED THAT THE PT CABLE COULD BE RETURNED. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED BY MASIMO TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "JUST WANTED YOU TO KNOW THAT I HAD A PT WITH THIS READ OUT ON HER SEDLINE. ISOELECTRIC EEG (SEE PIC BELOW), PRESSED ON THE DOTS AND GOT A REACTION THROUGH THE CABLE TO THE DEVICE, ALL THE DOTS WERE GREEN ON THE MONITOR DEMONSTRATING GOOD CONTACT, SO WE WERE THINKING SHE HAD A BAD PROBLEM. I CHANGED THE SWEEP SPEED AND VOLTAGE JUST TO BE CERTAIN THAT WASN'T AN ISSUE, BUT THE READOUT REALLY DIDN'T CHANGE. AFTER DISCUSSION WITH DR. RAMSAY AND OUR PHARMACIST WE STARTED TITRATING DOWN HER BENZOS AND FENTANYL. RETURNED TO SEE THE PT SEVERAL HOURS LATER AND EEG READOUT WAS UNCHANGED. I DISCUSSED THE CASE WITH OUR INTENSIVIST AND HE PUT IN AN ORDER FOR A FULL EEG. WHILE WAITING, OUT OF CURIOSITY, I CHANGED THE BOX AND THE CABLE AND STARTED GETTING THIS READOUT. SWITCHED THE NEW CABLE TO THE OLD BOX, AND THE EEG CONTINUED TO READ CORRECTLY, NO LONGER ISOELECTRIC. THIS IS NOT THE FIRST TIME I HAVE HAD THIS ISSUE WITH A CABLE THAT IS NOT PICKING UP THE EEG CORRECTLY, YET WE ARE STILL GETTING PSI AND DSA. THERE DOESN'T APPEAR TO BE ANY WARNINGS THAT THERE IS A CABLE ISSUE. I HAVE THE CABLE ON MY DESK. PLEASE ADVISE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595987 SEDLINE MODULE PATIENT CABLE OXIMETER GWQ MASIMO CORPORATION 24295
    596213 SEDLINE MODULE PATIENT CABLE OXIMETER GWQ MASIMO CORPORATION 24295

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death